What is the SeQuent® Please PACCOCATH® coating and how does it work?
PACCOCATH® coating is a mixture of Iopromide and Paclitaxel. Iopromide makes the PACCOCATH® coating a kind of porous, which is important to get Paclitaxel off the balloon surface. The matrix can be released easier from the balloon surface and it is fragmented into small units at inflation. These small units get dispersed upon the contact with blood. The Iopromid dissolves and the Paclitaxel migrates into the cell since it is attracted from the cell membrane. To pass the cell membrane and migrate into the nucleus of the cell Paclitaxel has to be available in form of single molecules and not in a compound of Paclitaxel molecules.
Where does the high drug delivery efficacy come from?
The matrix technology, which is a dispersion of Paclitaxel and Iopromid enables a high Paclitaxel load. Furthermore it makes Paclitaxel bioavailable, i.e. it is not embedded into a polymer coating but it is bound to the balloon surface in a reversible way.
How does Paclitaxel influence the cell proliferation?
Paclitaxel stops the cell proliferation in the clinically proven and well known way.
How long do I have to inflate the balloon for complete drug release?
An inflation time of at least 30 seconds is recommended.
How much drug is deposited in the vascular wall?
Clinical trials showed that about 16% of the initial drug load is delivered into the vascular tissue.
How long does the patient need dual platelet therapy after PTCA with SeQuent® Please?
We recommend 3 months, which is equal to medication time after BMS stent implantation.
How is Paclitaxel fixed to the balloon surface?
The matrix is a polymer free Paclitaxel coating of the balloon surface. Paclitaxel is lipophific and thereby attracted by the hydrophobic balloon surface. The difficulty is to bind it to the balloon surface in a reversible way. B. Braun developed a matrix containing Iopromide and Paclitaxel. Iopromide is the release agent and essential to make Paclitaxel bioavailable. Contrary to DES the DEB is polymer-free, i.e. Sequent® Please does not leave any residues in the body.
Why didn’t local drug delivery work in prior studies?
The limitation of prior devices was the low efficacy of the drug transfer into tissue of < 1%.
How to treat very narrowed, very calcified lesions or chronic total occlusions (CTO) with SeQuent® Please?
It is recommended in extremly complex patient morphologies to perform a pre-dilatation first by using a uncoated balloon catheter and subsequent to use the SeQuent® Please. The diameter shall be 0.5 mm smaller than the SeQuent® Please balloon intended for use. The inflation time has to be 30 sec unless severe ischemia occurs. This procedure will reduce any mechanical impact on the balloon coating and thereof it will support a maximum dosage supply to the target lesion site.
Can I use the SeQuent® Please twice?
No, each SeQuent® Please is allowed for single use only. After initial dilatation the positive effects of the active agent is gone. Of course, SeQuent® Please can be used as “uncoated” balloon” within the running procedure.
Which inflation pressure should be used with Sequent® Please? Is it nominal pressure enough if you have predilated?
Important is a complete contact between the fully inflated SeQuent® Please and the vessel wall. This diameter driven contact needs to be accomplished at whatever working range pressure needs to be applied.